FDA Inspection
Teva Puerto Rico LLCTeva Puerto Rico LLC – FDA Inspection, Apr 11, 2013
Record Details
This FDA Inspection record concerns Teva Puerto Rico LLC, with an inspection on April 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Teva Puerto Rico LLC
- Inspection Date
- April 11, 2013
- Product Type
- Drugs
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ID · 88a5464c-df28-49e9-9b66-8e06aeeb929a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 826944
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.67(b)(1)Cleaning SOP/responsibility
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Other FDA inspections of Teva Puerto Rico LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 23, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Puerto Rico LLC
- FDA Inspection 1193314 - 2022-11-23
- FDA Inspection 1064456 - 2018-08-10
- FDA Inspection 1010797 - 2017-03-03
- FDA Inspection 920580 - 2015-03-06
- FDA Inspection 800308 - 2012-09-13
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